What Concept of Manual Therapy is More Effective to Improved Health Status in Women With Fibromyalgia Syndrome?: An Experimental Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Quality of Life
- Sponsor
- Universidad Europea de Madrid
- Enrollment
- 52
- Locations
- 2
- Primary Endpoint
- Fibromyalgia Impact Questionnaire
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The aim of the study will be to find out which manual therapy approach is most effective for the improvement of symptoms (sensory, cognitive, emotional and social) in people with Fibromyalgia.
Detailed Description
A randomized clinical trial will be conducted in 52 patients with Fibromyalgia who will undergo a myofascial treatment approach or a passive mobilization treatment approach. Data will be collected on the improvement of symptom severity, quality of life, self-efficacy, kinesiophobia, catastrophizing, central sensitization, anxiety, depression, and sleep. After the treatments, follow-ups will be made, and the results are expected to be disseminated to the scientific community during and after the end of the study.
Investigators
Eleuterio Atanasio Sánchez Romero
Principal Investigator
Universidad Europea de Madrid
Eligibility Criteria
Inclusion Criteria
- •Less than 62 years old
- •Medical Diagnosis of Fibromyalgia
- •The individuals included in the study had a minimum one-year history of symptoms
- •To confirm the medical diagnosis of fibromyalgia, the physical therapists and study investigators used the 2010 American College of Rheumatology (ACR) diagnostic criteria. -Since 2 of the measurement variables used in the study (WPI and SS-Score) match the protocol when determining these criteria, this procedure was facilitated.
- •The diagnostic criteria establish the diagnosis of fibromyalgia when12 : IDG/WPI ≥ 7 and SS ≥ 5 or IDG/WPI 4-6 and SS ≥ 9.
Exclusion Criteria
- •Intolerance to touch
- •A change of medication in the last 2-3 months
- •Agree not to change their medication during the study
- •Exclusion Criteria:
Outcomes
Primary Outcomes
Fibromyalgia Impact Questionnaire
Time Frame: Change from baseline, immediately after the intervention with the different manual therapy protocols; and at 1, 2 and 3 months of follow-up after intervention
Another measurement variable will be the impact of fibromyalgia on quality of life, through the Fibromyalgia Impact Questionnaire (FIQ), a tool translated into Spanish by means of the international translation-retrotranslation recommendations, and whose reliability, validity, adaptation and sensitivity to change have been satisfactorily analyzed in Spanish patients with fibromyalgia. Consists of 19 items that measure three main categories (a) "function" - ten items that as-sess the participant's physical functions that address the participant's ability to perform each activity. This domain is assessed on a 4-point Likert scale, from 0 to 3 (0= always, 1= always, 1= always, 2= always, 3= always). 0 to 3 (0= always, 1= frequently, 2= occasional-ly, 3= never). (b) "Global impact" - composed of two items assessing the number of days in the last week when the participants felt good and the number of days they could not work due to FM symptoms
Pain Expansion
Time Frame: Change from baseline, immediately after the intervention with the different manual therapy protocols; and at 1, 2 and 3 months of follow-up after intervention
This will be classified as a continuous numerical variable measured by the Widespread Pain Index (WPI). In this index, the patient has to mark with an x the areas in which he/she has presented pain during the last week
Symptom severity
Time Frame: Change from baseline, immediately after the intervention with the different manual therapy protocols; and at 1, 2 and 3 months of follow-up after intervention
This variable will be classified as a continuous numerical variable, measured by the Symptom Severity Index (SSI/SS-Score), composed of two subscales (SS-1 and SS-2) that assess the intensity during the last week of 3 of the main symptoms present in FM (fatigue, unrefreshing sleep and cognitive disorders), as well as the presence/absence of other common symptoms, respectively. The total score of the SSS is the sum total and ranges from 0 to 12. The SSS correlated correlates strongly with the WPI (r=0.733) and with the presence of Tender Points (r=0.680)
Secondary Outcomes
- Depression(Change from baseline, immediately after the intervention with the different manual therapy protocols; and at 1, 2 and 3 months of follow-up after intervention)
- kinesiophobia(Change from baseline, immediately after the intervention with the different manual therapy protocols; and at 1, 2 and 3 months of follow-up after intervention)
- Self-Efficacy(Change from baseline, immediately after the intervention with the different manual therapy protocols; and at 1, 2 and 3 months of follow-up after intervention)
- Anxiety(Change from baseline, immediately after the intervention with the different manual therapy protocols; and at 1, 2 and 3 months of follow-up after intervention)
- Quality of life (EQ-5D-5L)(Change from baseline, immediately after the intervention with the different manual therapy protocols; and at 1, 2 and 3 months of follow-up after intervention)
- Sleep quality(Change from baseline, immediately after the intervention with the different manual therapy protocols; and at 1, 2 and 3 months of follow-up after intervention)
- Visual Analog Scale (VAS)(Change from baseline, immediately after the intervention with the different manual therapy protocols; and at 1, 2 and 3 months of follow-up after intervention)